Beloderm, 0.05% cream 15 g

GCS for external use.

It has anti-inflammatory, antipruritic, anti-allergic, vasoconstrictor, antiexsudative and antiproliferative effects.

When applied to the skin surface, the drug has a fast and strong action in the area of inflammation, reducing the severity of objective symptoms (erythema, edema, lichenification) and subjective sensations (itching, irritation, pain).

Indications

Conditions for which therapy with topical corticosteroids is effective, including:

Atopic dermatitis.
Neurodermatitis.
Allergic contact dermatitis.
Eczema (various forms).
Contact dermatitis (including occupational).
Non-allergic dermatitis (including solar and radiation dermatitis).
Reactions to insect bites.
Psoriasis.
Bullous dermatoses.
Discoid lupus erythematosus.
Lichen planus.
Exudative erythema multiforme.
Skin itching of various etiologies.

Pharmacological effect

GKS for external use.

It has anti-inflammatory, antipruritic, antiallergic, vasoconstrictor, antiexudative and antiproliferative effects.

When applied to the surface of the skin, the drug has a rapid and strong effect at the site of inflammation, reducing the severity of objective symptoms (erythema, swelling, lichenification) and subjective sensations (itching, irritation, pain).

Special instructions

Long-term use of the drug on the skin of the face is not recommended, because the development of rosacea, perioral dermatitis and acne is possible.

The drug should not be used in the eye area, due to the likelihood of the drug getting into the mucous membrane, which can contribute to the development of cataracts, glaucoma, fungal infections of the eye and exacerbation of herpetic infections.

Some areas of the body, such as the armpits, groin folds, where there is a natural occlusion, are more susceptible to the risk of stretch marks, so the use of the drug on these areas of the skin should be short-term.

If a fungal or bacterial infection develops on the skin, additional use of an antibacterial or antifungal agent is necessary.

Use in pediatrics

The drug can be prescribed to children from 6 months of age with caution and for the shortest possible time. The drug should not be used under bandages and, especially under plasticized diapers, because this enhances the absorption of the drug and increases the risk of side effects.

Impact on the ability to drive vehicles and operate machinery

There is no data on the adverse effects of Beloderm on the ability to drive vehicles and operate machinery.

Active ingredient

Betamethasone

Composition

Active substance:
betamethasone (in the form of dipropionate) – 0.640 mg, which corresponds to 0.500 mg of betamethasone;
Excipients:
chlorocresol,
sodium dihydrogen phosphate monohydrate,
phosphoric acid,
petrolatum,
mineral oil,
macrogol cetostearate,
cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%),
sodium hydroxide,
water.

Pregnancy

The use of Beloderm in pregnant women is permitted in cases where the expected benefit to the mother outweighs the risk to the fetus.

In such cases, the use of the drug should be short-term and limited to small areas of the skin.

During breastfeeding, the use of the drug is possible according to strict indications, but the drug should not be applied to the skin of the mammary gland before feeding.

Contraindications

Lupus.
Skin manifestations of syphilis.
Chicken pox.
Viral, bacterial and fungal skin infections.
Skin post-vaccination reactions.
Open wounds.
Trophic ulcers.
Rosacea.
Acne vulgaris.
Tumors of the skin and subcutaneous structures.
Children’s age up to 6 months.
Hypersensitivity to betamethasone or to any of the auxiliary components of the drug.

Side Effects

Side effects are usually mild.

Dermatological reactions: rarely – hypersensitivity reactions (itching, burning, hyperemia), acne-like changes, hypopigmentation, stretch marks, skin atrophy, hypertrichosis, telangiectasia, secondary skin infections.

If a hypersensitivity reaction or adverse reactions develop, the drug should be discontinued.

Interaction

The interaction of Beloderm with other drugs is unknown.

Overdose

Symptoms: with long-term continuous use of the drug, especially in children, on large surfaces of the skin, when applied to skin with impaired integrity or when used under an occlusive dressing, the development of side effects associated with suppression and insufficiency of the function of the adrenal cortex is possible.

Treatment: it is recommended to discontinue the drug and, if necessary, prescribe symptomatic therapy.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

4 years

Manufacturer

Belupo, medicines and cosmetics d.d., Croatia